Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet? Search our job listings below.
Senior Scientist for Analytical Development
There has never been a more exciting time to join Analytical Development in Elanco Animal Health. Our research and development pipeline is growing and the technologies we work on are broader than ever. Our products span medicated controlled release polymers such as Seresto ® collars through to injectable liposomal plasmid delivery systems for our highly innovative Zelnate® immunostimulant.
Small Molecule Technical Development (SMTD) has an exciting opportunity for an analytical chemist to join our product development organization in Greenfield, IN USA. You will be part of a diverse global team of analytical, formulation, and packaging scientists engaged in product development across a broad range of veterinary drug platforms.
Your Tasks and Responsibilities:
- Technical leadership in the analytical development of animal health products in Research and Development:
- Enable the design, development, and implementation of analytical methodologies for the characterization and analysis of small molecules including peptides in drug product formulations
- Show proficiency in multiple modes of chromatography (preferred), dissolution (preferred), LC-MS, optical spectroscopy, or other analytical techniques
- Development and validation of robust chromatographic methods
- Perform statistical analysis of chromatographic and dissolution data and integrate concepts of DoE into study designs
- Ensure adoption of state-of-the-art technologies and Quality by Design (QbD) development concepts as well as adherence to quality standards
- Establish analytical control strategy and specifications for drug product that can be transferred into manufacturing and successfully registered globally
- Design and implementation of VICH compliant stability studies conducted by external partners
- Engage with scientists across Elanco’s Development and Manufacturing organizations to develop a deep understanding of new initiatives and improve existing scientific processes
- Authoring of analytical submission documentation and coordination of the CMC sections (Part II CMC, Expert report) of dossiers for worldwide registrations including responding to technical questions from Health Authorities
- Professional input into the development of strategic concepts for the technical registration of animal health products in collaboration with Regulatory Affairs
- Optimization and defense of Elanco marketed products
- Analytical Subject Matter Expert for global project development teams
Basic Minimum Qualifications:
- PhD in a scientific discipline (e.g., Analytical Chemistry, Pharmaceutical Chemistry, Pharmacy, or equivalent) with 3+ years of experience in the pharmaceutical field
- Sound understanding of pharmaceutical analytical chemistry and analytical techniques such as HPLC/UPLC, Dissolution, GC, IR, UV, etc.
- Good working knowledge of ICH and/or VICH guidance and familiarity with GMP regulations
- Experienced in planning, design, and evaluation of Health Authority registration studies and compilation of CMC submission documentation for animal or human health products
- Experienced working in a pharmaceutical-oriented environment and in cross-functional project teams with a sustained bias for collaboration
- Possesses organizational and leadership skills with the ability to lead and inspire a team to deliver results with scientific excellence
- Strong written and verbal communication skills with the ability to translate complex scientific results into clear messages and speak to both technical and business-related implications of your work
- Broad IT skills (e.g., MS Office, eLN, Empower, Fusion QbD, JMP)
- Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status